ETHIBOND EXCEL X762HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031057920), received between Apr 5, 2023 and Aug 12, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 reports).

8 other recalls cover devices cleared under the same FDA submission (K946173); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MITRAL VALVE REPAIR ON AN UNKNOWN DATE AND SUTURE WAS USED. AORTIC VALVE PERFORATION OCCURRED WHEN MITRAL ANNULOPLASTY WAS PERFORMED. IT WAS FOUND THAT THE DOCTOR CONTACTED ABOUT THE DIAMETER OF NEEDLE/SUTURE AND THE BACKGROUND WAS CHECKED. THE DOCTOR WONDERED HOW BIG THE HOLE IN THE VALVE CUSP PERFORATION WAS BASED ON THAT EXPERIENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Mitral Perforation

  MAUDE report 22789582 ↗
• MalfunctionJul 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR ON (B)(6) 2024 AND SUTURE WAS USED. DURING A HERNIA SURGERY, THE NEEDLE WAS BROKEN DURING THE SURGERY ON JUNE 25. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19839982 ↗
• MalfunctionFeb 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2024; AND A SUTURE WAS USED. WHEN THE NEEDLE WAS PULLED WITH THE NEEDLE HOLDER, THE SUTURE WAS DETACHED FROM THE NEEDLE SMOOTHLY WITHOUT APPLYING TENSION, ALTHOUGH IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809327 ↗
• MalfunctionFeb 7, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THERE HAD BEEN A SINGLE-ARMED SUTURE THOUGH IT SHOULD HAVE BEEN A DOUBLE-ARMED. THE PRODUCT WAS NOT USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18659578 ↗
• MalfunctionOct 25, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SACROCOLPOPEXY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE THAT WAS SUPPOSED TO BE USED IN FIXING THE MESH WAS ALREADY FRAYED WHEN THE SURGEON TRIED TO USE IT, AND THE SUTURE BROKE DURING CONTINUOUS SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18008404 ↗
• MalfunctionApr 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. IT WAS FOUND THAT SOME SUTURES HAD BEEN DETACHED FROM THE NEEDLES. ALSO, SOME OF THE SUTURES WERE EASILY DETACHED FROM THE NEEDLES. THESE WERE NOT CONTROL RELEASE NEEDLES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686322 ↗
• MalfunctionApr 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. IT WAS FOUND THAT SOME SUTURES HAD BEEN DETACHED FROM THE NEEDLES. ALSO, SOME OF THE SUTURES WERE EASILY DETACHED FROM THE NEEDLES. THESE WERE NOT CONTROL RELEASE NEEDLES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686261 ↗
• MalfunctionApr 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. IT WAS FOUND THAT SOME SUTURES HAD BEEN DETACHED FROM THE NEEDLES. ALSO, SOME OF THE SUTURES WERE EASILY DETACHED FROM THE NEEDLES. THESE WERE NOT CONTROL RELEASE NEEDLES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686175 ↗
• MalfunctionApr 5, 2023Material Separation; Material Separation

  IT WAS REPORTED, THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022, AND SUTURE WAS USED. IT WAS FOUND THAT SOME SUTURES HAD BEEN DETACHED FROM THE NEEDLES. ALSO, SOME OF THE SUTURES WERE EASILY DETACHED FROM THE NEEDLES. THESE WERE NOT CONTROL RELEASE NEEDLES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16685318 ↗
• MalfunctionApr 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. IT WAS FOUND THAT SOME SUTURES HAD BEEN DETACHED FROM THE NEEDLES. ALSO, SOME OF THE SUTURES WERE EASILY DETACHED FROM THE NEEDLES. THESE WERE NOT CONTROL RELEASE NEEDLES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16685282 ↗
• MalfunctionApr 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. IT WAS FOUND THAT SOME SUTURES HAD BEEN DETACHED FROM THE NEEDLES. ALSO, SOME OF THE SUTURES WERE EASILY DETACHED FROM THE NEEDLES. THESE WERE NOT CONTROL RELEASE NEEDLES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16685268 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K946173. One submission often covers many models, so check the product and lot details in each record.

• Z-1516-2025 · Mar 7, 2025 · Open, Classified
  ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
• Z-1097-2025 · Dec 20, 2024 · Open, Classified
  PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovas
• Z-2486-2020 · Jun 10, 2020 · Open, Classified
  PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870
• Z-1842-2019 · Apr 19, 2019 · Terminated
  ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue appr
• Z-1841-2019 · Apr 19, 2019 · Terminated
  ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue app
• Z-0747-2019 · Dec 18, 2018 · Terminated
  PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approxima
• Z-1839-2015 · May 8, 2015 · Terminated
  Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast ab
• Z-0492-2015 · Oct 17, 2014 · Terminated
  Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.